Senior Program Manager-Regulatory Affairs

04 Aug, 2022

Jobs

Senior Program Manager-Regulatory Affairs

Phillips
Remote

Job Title

Senior Program Manager-Regulatory Affairs

 

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*.  Employees may request a reasonable accommodation.*Montana employees are currently excluded from this requirement at this time.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.  You may contact 888-367-7223, option 5, for assistance.

 

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

 

In this role, you have the opportunity to make life better:

Exciting opportunity to utilize your Program/Project management expertise to lead project teams with a focus on regulatory compliance, and market expansion within our existing product portfolio.  This role will lead and manage regulatory compliance activities focused on Electronic Medical Records & Care Management (EMR&CM) in domestic and international markets for assigned medical devices.

 

You are responsible for:

  • Engaging senior business leadership to establish strategic direction and scope for applicable projects and programs
  • Builds appropriate programing pipelines working across business units to achieve Business Cluster strategic compliance objectives generating a delivery plan for the next year through the next 2-3 years
  • Collaborating with cross-functional team members to ensure program success
  • Providing work direction, technical guidance, coaching and mentorship to other project managers, engineers and cross-functional team members
  • Evaluating project ideas to determine which sustaining activities should be pursued by the business.
  • Making data driven decisions using appropriate analytical methodologies
  • Provide financial input on project and program costs and budgeting
  • Develop milestones, tasks, and schedules to meet project, program, and business needs.
  • Perform project risk management to de-risk project risks and provide mitigations
  • Translating user needs and regulatory expectations and interpretation of standards into clear, concise project requirements to support continued market access and business expansion
  • Preparing for and conduct various design reviews in accordance with regulatory requirements
  • Support regulatory team to ensure functional requirement documentation identifies the ability to meet regional regulatory requirements and assessing legacy product documentation for adequacy and appropriateness
  • Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
  • Providing independent judgment in developing methods, techniques, and evaluation criteria for product related research and development specifically as it relates to legacy product information and changing regulatory expectations
  • Identifies needed resources for projects, defines and assigns major project roles
  • Monitors the program/project from initiation through delivery, interfacing with internal/external customers
  • Responsible for ensuring compliance with relevant internal policies, procedures, and standards
  • Assigns and monitors work of project management staff, providing support and direction.

 

You are a part of:
A team of talented Regulatory affairs professionals working independently on the Regulatory duties, processes and roles.  Our team supports the EMR & CM business, which consists of sustaining products and innovative technology software devices.

 

To succeed in this role, you’ll need a customer-first attitude and the following:

  • Minimum of a Bachelor’s degree, RAPS Certification desired
  • Minimum of 7+ years’ experience in structured project/program management in a regulated industry, with FDA regulated medical device highly preferred.
  • Experience in regulatory affairs, or interacting with health authorities is highly preferred
  • Class II and Class III Medical Device product experience desired
  • Knowledge of US FDA CFR 820, EU-MDR, ISO 13485 and other developed and emerging market regulatory requirements
  • Working knowledge of typical medical device standards such as ISO 14971, ISO 10993-X, ISO 62304, ISO 10555, ISO 80369, etc.
  • Experience managing technical activities of a project as a core team member of a large cross-functional/site team
  • Demonstrated ability to balance data driven decisions with business outcomes in mind
  • Analytical knowledge to drive data driven decisions throughout development cycle
  • Strong technical writing ability and experience writing product requirements, specifications, test protocols, and test reports
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and teammates
  • Excellent organizational, communication, and collaboration skills
  • PMI-PMP Certification desired
  • Structured Project Management Process-Stage-Phase Gate, Agile/Waterfall, DMAIC etc.
  • Knowledge in critical path methodology, and ideally with critical chain methodology
  • Robust knowledge of design controls and risk management standards
  • Strong experience in the creation of project plans, budgets, and schedules
  • Extensive experience leading cross-functional Product Development Project teams

 

In return, we offer you:

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

 

Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

#LI-PH1

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

 

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Opportunity Employer/Disabled/Veteran

Learn more here

Job posted: 2022-08-04